FDA Puts Opioids, Compounding, Stem Cells at Forefront of Enforcement Efforts
By Zachary Brennan -
Published 06 December 2017
The US opioid epidemic, drug compounding and the proliferation of stem cell clinics selling unproven treatments were highlighted as some of the focal points for US Food and Drug Administration (FDA) enforcement efforts last year and next year, officials said Wednesday at the Food and Drug Law Institute’s litigation and compliance conference in Washington, D.C.
Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs
Tags: opioids, FDA enforcement, FDA compliance, FDLI, stem cells
Califf: Leveraging Real World Evidence is 'Top Programmatic Priority' for FDA
By Michael Mezher -
Published 11 May 2016
The "top programmatic priority" for the US Food and Drug Administration (FDA), under Commissioner Robert Califf, is to leverage real world evidence from the healthcare system to inform FDA decision making, he told participants at the Food and Drug Law Institute's annual conference last week.
Categories: News, US, FDA, Clinical, Drugs, Regulatory strategy, Submission and registration
Tags: Real world evidence, Sentinel, Robert Califf, FDLI